Systemic, Pancoronary and Local Coronary Vulnerability

NCT03606330 | Completed

• 1 other identifier: CM0118-PLI-3
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

• The aim of the VIP study is to investigate the impact of vulnerability markers (inflammatory serum biomarkers for systemic vulnerability, coronary shear stress and vulnerability mapping for pancoronary vulnerability, and imaging-based plaque features for systemic vulnerability) on the rate of major adverse cardiovascular events caused by progression of the non-culprit lesion in patients with acute ST or non-ST segment elevation myocardial infarction who undergo revascularization of the culprit lesion during the acute event. Furthermore, the study will evaluate the rate of progression of non-culprit lesions towards a higher degree of vulnerability, based on coronary computed tomography angiographic assessment at 1 year after enrollment.

Conditions

Coronary Stenosis; Acute Coronary Syndrome; Acute Myocardial Infarction; Atheromatous Plaques; Atheroscleroses, Coronary; Non-ST Elevation Myocardial Infarction (nSTEMI)

Keywords

coronary artery disease; myocardial infarction; cardiac imaging techniques; major adverse cardiovascular events; vulnerable coronary plaques; serum biomarkers; coronary shear stress

Outcome Measures

Primary Outcomes (1)

• MACE rate - Major adverse cardiovascular events

  Acute coronary syndromes (unstable angina, ST and non-ST elevation myocardial infarction), emergency revascularization of non-culprit lesions, repeated hospitalizations for cardiovascular reasons, acute cerebrovascular event.

  36 months

Secondary Outcomes (2)

• Severity progression of non-culprit coronary lesions

  12 months

• Progression rate of CT markers for coronary plaque vulnerability

  12 months

Study Arms (2)

VP-SG 01

Study subjects that present MACE at the 36 months follow-up

Diagnostic Test: Cardiac imaging tests; Diagnostic Test: Venous blood sample collection

VP-SG 02

Study subjects that do not present MACE at the 36 months follow-up

Diagnostic Test: Cardiac imaging tests; Diagnostic Test: Venous blood sample collection

Interventions

Cardiac imaging tests DIAGNOSTIC_TEST

* 2D transthoracic echocardiography * 128-multislice CT coronary angiography with the evaluation of: epicardial fat volume, plaque burden, total and local calcium score, markers for lesion severity; morphological plaque characteristics; plaque components evaluated via volumetric and planimetric units; markers of plaque vulnerability (necrotic core, low attenuation plaque, spotty calcification, napkin ring sign, positive remodeling). * Shear stress evaluation via computational fluid dynamics. * Intracoronary imaging techniques: IVUS and OCT.

VP-SG 01; VP-SG 02

Venous blood sample collection DIAGNOSTIC_TEST

Venous blood sample collection during the acute coronary event for evaluation of serum levels of hsCRP, IL-6, matrixmetalloproteases MMP9, Adhesion molecules (VCAM, ICAM), alfa tumour necrosis factor, hs-cTnI, NTproBNP

VP-SG 01; VP-SG 02

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 patients with present ST and non-ST segment elevation myocardial infarction at 30 days prior to study enrollment, who underwent emergency revascularization of the culprit lesion.

You may qualify if:

• Patients aged over 18 years old that have signed the written informed consent;
• Patients with ST and non-ST segment elevation myocardial infarction (as stated in the Third Universal Definition of Myocardial Infarction) at 30 days prior to randomization;

You may not qualify if:

• unwillingness or incapacity to provide informed consent (and if consent of legal guardian or family is not available);
• acute myocardial infarction at the moment of randomization (as these patients are referred to the hospital for emergency invasive coronary angiography and revascularization)
• conditions that present an estimated life expectancy of under 5 years;
• acute renal failure or terminal stage chronic kidney disease;
• pregnancy or lactation and women of reproductive age who are not using any contraceptive method;
• allergy and history of allergic reactions to iodine contrast media;
• active malignancy or malignancy within the last 1 year prior to enrollment;
• patients who, in the opinion of the investigators are not compliant and will not present for study visits.

Sponsors & Collaborators

• Cardio Med Medical Center: lead
• University of Targu Mures, Romania: collaborator
• University Hospital of Targu Mures, Romania: collaborator

Study Sites (1)

Cardio Med

Târgu Mureş, Mureș County, Romania

Location

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood sample collection during the acute coronary event for evaluation of serum levels of hsCRP, IL-6, matrixmetalloproteases MMP9, Adhesion molecules (VCAM, ICAM), hs-cTnI, NTproBNP

MeSH Terms

Conditions

Coronary Stenosis; Acute Coronary Syndrome; Plaque, Atherosclerotic; Coronary Artery Disease; Non-ST Elevated Myocardial Infarction; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Theodora Benedek, Professor

  Cardio Med Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 30, 2018
• Study Start: October 22, 2018
• Primary Completion: October 22, 2019
• Study Completion: March 1, 2022
• Last Updated: August 2, 2022

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The IPD sharing frame is starting 6 months after publication.

Locations

RO (1)